Remote Principal Statistical Programmer (SAS/R)

Jobgether; Las Palmas de Gran Canaria; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated clinical programs within a pharmaceutical client setup. You will implement reporting and analysis activities, lead SDTM/ADaM development, and oversee CRO programmers to ensure high-quality outputs.

You will contribute to regulatory submissions, study reports, and exploratory analyses, while adhering to FDA guidelines and GCP.

Qualifications

• Extensive experience with SAS programming for clinical trials.
• Strong knowledge of SDTM/ADaM data structures.
• Experience with regulatory submissions and GCP.
• Ability to oversee CRO programmers and deliver high-quality outputs.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables, and graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses
• Understand FDA regulations affecting reporting of clinical trial data, including GCP and eSubmissions
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in development of CRFs, edit check specifications, and data validation plans
• Provide review of data transfer specifications for external vendor data
• Collaborate with internal and external functions to meet timelines and goals

Connaissances

SAS programming

R programming

SDTM

ADaM

Regulatory submissions

Clinical trial data

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated clinical programs within a pharmaceutical client setup. You will implement reporting and analysis activities, lead SDTM/ADaM development, and oversee CRO programmers to ensure high-quality outputs.

You will contribute to regulatory submissions, study reports, and exploratory analyses, while adhering to FDA guidelines and GCP.